Products
As urged by the AHA and its professional membership group the Association for Health Care Resource & Materials Management, the Food and Drug Administration yesterday released guidance to help hospitals and other health care providers conserve pneumatic tourniquet cuffs after a recent recall led…
In response to questions from AHA and others and informed by testing results, the Food and Drug Administration April 21 announced that health care providers without alternative options may continue to use a certain version of the O&M Halyard FLUIDSHIELD Surgical N95 Respirator Mask for fluid…
The Food and Drug Administration today withdrew approval for Makena and its generics, citing a confirmatory study that did not verify clinical benefit. Makena had been approved under the FDA’s accelerated approval pathway to reduce the risk of preterm birth in women pregnant with one baby who have…
The U.S. Food & Drug Administration has issued a Class I recall, the most serious type of recall, for the Arrow MAC Two-Lumen Central Venous Access Kits and Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter Kits.
Philips has reported two potential issues with Respironics Trilogy ventilators that were recalled in June 2021 and reworked, the Food and Drug Administration announced last week. The silicone sound abatement foam used to replace the polyester-based polyurethane foam may separate from the plastic…
The Food and Drug Administration this week alerted health care providers to a shortage of tracheostomy tubes, used to help people breathe after a tracheotomy, including a tube made by ICU Medical for pediatric patients.
Exela Pharma Sciences this week recalled 49 lots of sodium bicarbonate injection because the vial may break while preparing the product for administration, causing glass to fly.
Covidien LLC (Medtronic) recently recalled more than 1 million Palindrome and Mahurkar Hemodialysis Catheters due to a defect that could cause serious injury or death.
Smiths Medical recently recalled more than 118,000 Medfusion syringe infusion pumps whose software could malfunction, the FDA announced.
GE Healthcare is recalling 4,222 backup batteries for its CARESCAPE R860 ventilator in the United States.